External Battery Assembly

GUDID 09353645350520

Mobi External Battery

RESMED ASIA PTE. LTD.

Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack Portable/mobile rechargeable battery pack
Primary Device ID09353645350520
NIH Device Record Key9f9961e8-119f-4713-946d-946f82dfb96f
Commercial Distribution StatusIn Commercial Distribution
Brand NameExternal Battery Assembly
Version Model Number35052
Company DUNS659276906
Company NameRESMED ASIA PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com
Phone800-427-0737
Emailreception@resmed.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109353645350520 [Primary]

FDA Product Code

CAWGenerator, Oxygen, Portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-04-04
Device Publish Date2018-08-01

Devices Manufactured by RESMED ASIA PTE. LTD.

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09353645350520 - External Battery Assembly2023-04-04Mobi External Battery
09353645350520 - External Battery Assembly2023-04-04 Mobi External Battery
09353645000098 - Charger AC/DC with power cord2021-07-22 Activox, Charger AC/DC with power cord
09353645350537 - AC/DC Charger US2021-07-22 AC/DC Charger US (AMO)
09353645401062 - Oxyensure AC/DC Charger US2021-07-22 Oxyensure POC AC/DC Charger US (AMO)
09353645000562 - Mobi2021-01-18 Mobi - Refurbished
09353645000104 - Charger DC/DC2020-04-20 Activox, Charger DC/DC
09353645350018 - Mobi2020-04-20 Mobi AMER1 (AMO)

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